Safety and Efficiency of the Universal CNK-UT009 in Difficult-to-treat Inflammatory Bowel Disease Patients
Starting soon · Phase 1
Conditions studied: Inflamatory Bowel Disease, Crohn Disease (CD), Ulcerative Colitis (UC)
In brief
Inflammatory bowel disease patients who failed from at least two types of biologics or suffered refractory after at least twice surgery are defiened as difficult-to-treat IBD. It is reported a low five-year suvival rate around 15% of difficult-to-treat IBD patients. Cell therapy is a promising new strategy in auto-immune diseases beyond malignant cancers. Inbalanced immune microenvironment contribute to IBD and cell therapy should be a brighting selection of difficult-to-treat IBD. CNK-UT009 is an universal cellular immunotherapy targeted to auto-reactive T cells whose safety and effect were proved in patients with GVHD and type 1 diabetes mellius. Here, we conducted a single-arm open-label exploratory clinical study of CNK-UT cell therapy on difficult-to-treat IBD patients, mainly to explore the safety and define the maximum tolerated dose. Besides, the preliminary effect would also be evaluated.
Key facts
- Study ID
- NCT07416383
- Run by
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- People needed
- 40
- Starts
- 2026-04-01
- Expected to finish
- 2031-12-31
- Last updated by the study team
- 2026-02-18
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- diagnosed moderate-to- severe IBD patients
- defiened as difficult-to-treat(failed from at least two types of biologics or small molecular drugs, or refractory from at least twice of intestinal surgery)
- with complete bone-marrow and organic function
- no pregnant or planning to become pregnant
- welling to paticipate
You may not qualify if…
- patients with active infections or latent infections, malignant tumors, recent serious infections(within two weeks)
- patients paticipated other clinical trials with four weeks
- patients with drug combination other than low-dose glucocotiod
- patients recieved abdominal surgery or live vaccine
- patients with planned surgery in three months
- unsuitable situations determined by researchers
Full record on ClinicalTrials.gov
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